The present invention is directed to a closure appliance for use in connection with surgical ostomy and which, by virtue of its particular shape and structure, offers considerable improvements as compared to the currently available appliances.
The problems normally arising with ostomy closure appliances at present, especially in cases of abdominal colostomy, relate to the sealing action of the stoma. In fact the majority of the appliances employed for sealing the stoma comprise a magnetic ring which is located as a fitting around the stoma tube and implanted in the proximity of the patient's skin such that it holds the actual closure member in place by means of the magnetic attraction between the ring and one or more magnetic nuclei provided in the closure member. These closure members generally consist of a body situated on the outside of the stoma rigidly attached to another body which is inserted into the interior of the stoma. The outer body has incorporated therein magnetic elements which due to the magnetic attraction existing between these elements and the implanted ring, cause the closure of the stoma. This action can be enhanced by further magnetic elements located in the interior body.
Use of appliances as described above gives rise to problems with respect to the sealing effectiveness of the closure in view of the fact that the magnetic attractive force between the magnetic ring whih has been implanted in the patient and the magnetic nuclei which are located within the closure component varies as a function of the relative distance between them. This distance is subject to variations over a period of time, given that the patient's morphology is subject to evolution, virtually never remaining stable, with an increase or a decrease in the adipose tissue or the layer separating the implanted ring and the surface of the skin on which the closure appliance has been fitted. This gives rise to serious inconveniences with the increase or decrease of the distance resulting in a change in the mutually attractive forces and hence an adverse change in the sealing action of the closure appliance.
These inconveniences were disclosed in the Spanish Utility Model No. 274,978 and a solution was put forward in this patent, in the form of a movable magnetic element in the body of the closure appliance which is fitted in the interior of the stoma and which in some manner permitted the magnetic force between the implanted ring and the closure appliance to be varied.
On other occasions experiments have demonstrated that the rigidity of the closure appliances frustrates a solution to the problem of sealing by not allowing a satisfactory adaptation to the stoma. This problem is compounded by the positioning of the member to be inserted in the patient in that it is difficult to ensure the parallelism between the inserted member and the abdominal surface and thus the relative position of the insert may vary with the posture of the patient thus producing an angularity of the closure device relative to the abdomen and thus opening a passage of incontinency for liquids and solids.
The appliance which is the object of the present invention provides a solution to the disadvantages described above in that it comprises a closure device consisting of a component made in a highly flexible material such as silicone and of which the lower member, designed to be inserted within the stoma has disposed therein a magnetic element and a plurality of tubes permitting the exhaustion of fluids from inside the stoma. These tubes open into a cavity in an upper member, there being housed within the cavity an absorbent material and another filtration material which respectively absorb and filter the liquids and gases which arrive in the cavity proceeding from the interior of the stoma.
The upper member may incorporate preferably an element of greater consistency, providing greater rigidity in that member. In addition the upper member may be fitted with a detachable cover.
Experiments carried out by the applicant have demonstrated that the elasticity of the material of which the appliance is made, together with the rotula effect resulting from the flexible and elastic joint uniting the interior and exterior members result in a perfect adaptation of the stoma wall to the lower or internal member of the appliance and hence a hermetic and watertight seal of the stoma.
The above considerations have led the applicant to include in the design a plurality of tubes for the evacuation of the fluids from the lower member of the appliance. To achieve this the magnetic element which is housed within the interior of the lower member of the appliance is provided with a central orifice and the lower member has an internal void shaped to conform to the shape of the magnetic element. The central orifice in the magnetic element has located within it a stem in which there is a plurality of passageways providing for the outlet of fluids from the interior of the stoma, through the full length of the lower member of the appliance to the cavity provided in the upper member of the appliance.
Equally it has been demonstrated that the continual evacuation of the gases emanating from the stoma together with the presence of mucous in the colon result in the need to change, at frequent intervals, the filters and the absorbent material which has been provided in the outer member of the closure appliance. This consideration has led to the arrangement which allows for the provision, in the applicant's design, of an easily detachable cover of a material suitable for discarding and which, in turn, incorporates the elements required for the filtration of the gases and the absorption of liquids. The cover can be readily replaced by the patient with a new one when this becomes necessary.
According to the present applications there is the provision for the patient to fix to the external member either a detachable cover which incorporates an orifice allowing the escape of gases to the exterior or alternatively a cover which provides a tight seal without the use of orifices such that the patient, at his option, may use one or the other alternatives in accordance with the needs of his daily routine, that is, as to whether he wishes to allow the escape of the gases from the stoma, or not.
The cover without the orifices permits the patient to ensure that the stoma is isolated from the outside when, for example, he is bathing and thus desires to prevent the penetration of water into its interior.
In one preferred embodiment, the detachable cover has incorporated therein the filtration material for the gases as well as the absorbent material for the liquids which emanate from the stoma and is preferably made of a throw-away material for a one-time use only. This facilitates the handling of the cover and the replacement of the cover by the user-patient.
A further feature of the present application is the provision in the cover of the void which communicates downwardly with the tube coming from the stoma such that it is surrounded laterally by the absorbent element and is closed at its upper face by the filter material. This arrangement facilitates the collection of gases and liquids, allowing the liquids and gases to flow from the stoma into the void as they emerge from the former. The liquids are then absorbed by the absorbent walls and the gases pass through the upper filtration material so that they may then pass to the exterior through the orifices provided in the upper portion of the cover.
This arrangement, providing for the separate evacuation of the gases and the liquids, prevents the combination of some of the liquid with the flow of gases and hence avoids a possible blockage of the filter material.
The structure of the absorbent and filtration materials may take the form either of an annulus of absorbent material on which is placed a disc of the filtration material having the same external diameter as the former or of an annulus of absorbent material with the filtration material housed in the central zone of the said annulus.
The cover is completed by providing means for its attachment to the ostomy closure appliance and also the incorporation in its upper part of means for allowing a visual estimation of the percentage of absorbed product in the absorbent material, as for example, a device which indicates by a colour change the degree of humidity in the absorbent material.
This closure appliance, upon being fitted into the stoma, following implantation of the magnetic ring, will ensure that the exterior member will remain adapted to the mouth of the stoma and hence close it, and will permanently maintain itself in that position by virtue of the magnetic mutual attraction between the implanted ring and the magnetic element housed within the interior member of the closure appliance. Also in view of the flexibility of the union between the interior member and the exterior member, the interior member is free to move angularly with respect to the exterior member in a rotula movement, and as a consequence, the angle of the stoma axis with respect to the magnetic element embedded in the inner member, corrects itself for a lack of perpendicularity in the appliance by seeking the position of least magnetic reluctance, thus providing a correct operation of the closure characteristic of the appliance.
For a better understanding of the general characteristics of the ostomy closure appliance of the present invention, there are attached to this specification, descriptive drawings illustrating one practical embodiment of the same in accordance with the principles recited in the claims but with the observation that the sketches as drawn must be interpreted in their most general sense without implying any restrictive character in any form.